ethambutol hydrochloride

Generic: ethambutol hydrochloride

Labeler: american health packaging
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ethambutol hydrochloride
Generic Name ethambutol hydrochloride
Labeler american health packaging
Dosage Form TABLET
Routes
ORAL
Active Ingredients

ethambutol hydrochloride 400 mg/1

Manufacturer
American Health Packaging

Identifiers & Regulatory

Product NDC 68084-280
Product ID 68084-280_3f1882fc-606c-8c87-e063-6294a90aa227
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078939
Listing Expiration 2026-12-31
Marketing Start 2009-12-16

Pharmacologic Class

Classes
antimycobacterial [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68084280
Hyphenated Format 68084-280

Supplemental Identifiers

RxCUI
995607
UNII
QE4VW5FO07

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name ethambutol hydrochloride (source: ndc)
Generic Name ethambutol hydrochloride (source: ndc)
Application Number ANDA078939 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 400 mg/1
source: ndc
Packaging
  • 100 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-280-01) / 1 TABLET in 1 BLISTER PACK (68084-280-11)
source: ndc

Packages (1)

68084-280-01 100 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-280-01) / 1 TABLET in 1 BLISTER PACK (68084-280-11)

Ingredients (1)

ethambutol hydrochloride (400 mg/1)

Linked Drug Pages (1)

Ethambutol Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "3f1882fc-606c-8c87-e063-6294a90aa227", "openfda": {"unii": ["QE4VW5FO07"], "rxcui": ["995607"], "spl_set_id": ["d32e9865-8edd-4644-9939-62ed119db3ef"], "manufacturer_name": ["American Health Packaging"]}, "finished": true, "packaging": [{"sample": false, "description": "100 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-280-01)  / 1 TABLET in 1 BLISTER PACK (68084-280-11)", "package_ndc": "68084-280-01", "marketing_start_date": "20091216"}], "brand_name": "Ethambutol Hydrochloride", "product_id": "68084-280_3f1882fc-606c-8c87-e063-6294a90aa227", "dosage_form": "TABLET", "pharm_class": ["Antimycobacterial [EPC]"], "product_ndc": "68084-280", "generic_name": "Ethambutol Hydrochloride", "labeler_name": "American Health Packaging", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ethambutol Hydrochloride", "active_ingredients": [{"name": "ETHAMBUTOL HYDROCHLORIDE", "strength": "400 mg/1"}], "application_number": "ANDA078939", "marketing_category": "ANDA", "marketing_start_date": "20091216", "listing_expiration_date": "20261231"}